Thomas Alyssa, Mott Joseph, Antwiler Karen
J Addict Med. 2025 Jul 2. doi: 10.1097/ADM.0000000000001542.
Samidorphan is an opioid receptor antagonist and naltrexone analogue that has been harnessed in unique ways. Samidorphan has been paired with olanzapine in the new oral agent Lybalvi, approved by the FDA in 2021 for the treatment of schizophrenia and bipolar I disorder. The addition of samidorphan to olanzapine has the intention of reducing olanzapine's metabolic side effects (ie, weight gain), however, samidorphan's antagonism of the mu opioid receptor can lead to complications in patients with opioid use disorder on agonist therapy. These complications include not just precipitated withdrawal, as explored in prior case studies, but also the risk of reduced opioid tolerance and overdose in the event of olanzapine/samidorphan (Lybalvi) discontinuation and concurrent opioid use.
A 42-year-old female with a history of opioid use disorder, posttraumatic stress disorder (PTSD), and bipolar disorder presented to an opioid treatment program for buprenorphine/naloxone (BUP/NX) continuation. On presentation, she was being treated with a combination of olanzapine/samidorphan (Lybalvi) for bipolar disorder and 18 mg/d of transmucosal BUP/NX for opioid use disorder. Due to concern for interaction between buprenorphine and samidorphan, she was gradually tapered to a lower dose of buprenorphine to allow for discontinuation of olanzapine/samidorphan then titrated to an effective buprenorphine dose for long-term treatment.
This case report outlines the safety concerns of utilizing an opioid antagonist (samidorphan) in conjunction with an opioid partial agonist (buprenorphine) and demonstrates the process for safe transition to an alternative regimen.
沙米朵芬是一种阿片受体拮抗剂，也是纳曲酮类似物，其应用方式独特。沙米朵芬已与奥氮平联合用于新型口服制剂Lybalvi中，该制剂于2021年获美国食品药品监督管理局（FDA）批准，用于治疗精神分裂症和双相I型障碍。在奥氮平中添加沙米朵芬旨在减少奥氮平的代谢副作用（即体重增加），然而，沙米朵芬对μ阿片受体的拮抗作用可能会给接受激动剂治疗的阿片类物质使用障碍患者带来并发症。这些并发症不仅包括先前病例研究中探讨的戒断反应，还包括在停用奥氮平/沙米朵芬（Lybalvi）并同时使用阿片类物质的情况下，阿片耐受降低和过量用药的风险。
一名42岁女性，有阿片类物质使用障碍、创伤后应激障碍（PTSD）和双相情感障碍病史，前往阿片类物质治疗项目继续接受丁丙诺啡/纳洛酮（BUP/NX）治疗。就诊时，她正在接受奥氮平/沙米朵芬（Lybalvi）联合治疗双相情感障碍，以及每日18毫克经黏膜BUP/NX治疗阿片类物质使用障碍。由于担心丁丙诺啡和沙米朵芬之间的相互作用，她逐渐减少丁丙诺啡剂量，以便停用奥氮平/沙米朵芬，然后滴定至有效的丁丙诺啡剂量进行长期治疗。
本病例报告概述了联合使用阿片拮抗剂（沙米朵芬）和阿片部分激动剂（丁丙诺啡）的安全问题，并展示了安全过渡到替代治疗方案的过程。
